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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00590031 |
Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.
Condition | Intervention | Phase |
---|---|---|
Esophageal Carcinoma |
Drug: Cisplatin Drug: Irinotecan Radiation: External Beam Radiation Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan. |
Enrollment: | 61 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
External Beam Radiation Therapy, Cisplatin, Irinotecan
|
Drug: Cisplatin
pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
Drug: Irinotecan
Irinotecan will be given 65 mg/m2
Radiation: External Beam Radiation Therapy
will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Peter Scardino, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center ( David Ilson MD, PhD ) |
Study ID Numbers: | 02-045, IND 65889 |
Study First Received: | December 26, 2007 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00590031 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Esophageal Carcinoma Cisplatin Irinotecan Radiation Therapy 02-045 |
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Irinotecan Esophageal Cancer Carcinoma Digestive System Diseases Radiation-Sensitizing Agents |
Cisplatin Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Esophageal Neoplasms Physiological Effects of Drugs Irinotecan Enzyme Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Digestive System Diseases Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |